Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in BMD over the 2 year study period comparing treatment and placebo groups
研究概览
简要总结
Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the skin. Prevention of osteoporosis is a high priority, because treatment of the established disease remains sub-optimal.
We have designed a double-blind randomised controlled trial of two years' duration including 90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.
The primary objective of this study is to determine changes in BMD over the 2 year study period comparing treatment and placebo groups.
The most important secondary objective is to determine cytokine profiles in blood samples. We will also assess parameters related to vitamin D status and physical performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 50 years
- •EDSS < 4.0 (able to walk without rest some 500 m)
- •Women have to be premenopausal
- •MS according to the McDonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential)
- •Having given written informed consent.
排除标准
- •Pregnancy or unwillingness to use contraception; alcohol or drug abuse
- •Use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses
- •Known allergy to cholecalciferol or arachis oil (peanuts)
- •Therapy with digitalis, calcitonin, active vitamin D3 analogues, fluoride, or bisphosphonates during the previous 12 months
- •Any condition predisposing to hypercalcaemia
- •Nephrolithiasis or renal insufficiency
- •Presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.
结局指标
主要结局
Changes in BMD over the 2 year study period comparing treatment and placebo groups
时间窗: 2 years
次要结局
- Ratings on a fatigue scale(2 years)
- The number of patients without progression of disability judged by EDSS and(2 years)
- Reported infections(2 years)
- Cytokine expression following vitamin D supplementation(2 years)
- Contribution of vitamin D from different sources (generation in the skin, diet and supplements) to serum 25(OH) vitamin D (vitamin D status)(2 years)
- Changes in parameters of lower extremity function over the 2 year study period(2 years)
- The number of relapses, the time to first relapse, the number of relapse-free patients(2 years)